FDA UDI
In Commercial Distribution
🇺🇸 United States
SYNOJOYNT
DI: 00357844181137
·
Model: 57844-181
·
TEVA PHARMACEUTICALS USA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Basic Information
- Brand Name
- SYNOJOYNT
- Primary DI
- 00357844181137
- Version / Model
- 57844-181
- Catalog Number
- 57844-181
- Company Name
- TEVA PHARMACEUTICALS USA, INC.
- Labeler DUNS
- 001627975
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2019-05-08
- Public Version
- 1
- Public Version Date
- 2019-05-16
- Public Version Status
- New
- Public Device Record Key
- c659f2e0-66cc-4069-a22a-ee869cc6f828
Device Description
prefilled syringe
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MOZ | Acid, hyaluronic, intraarticular | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44757 | Synovial fluid supplementation medium | A sterile viscous/elastic solution or gel (e.g., comprised of hyaluronic acids and their polymeric derivatives) intended to be injected into joints (particularly large, load-bearing joints such as the hip or knee) to help cushion the joint, especially in cases of endogenous synovial fluid reduced viscosity from degenerative disease. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30357844181138 | GS1 | Shipping Case | 30 | In Commercial Distribution | |
| Primary | 00357844181137 | GS1 | ||||
| Unit of Use | 00357844181212 | GS1 |
Customer Contacts
- Phone
- +1(888)838-2872
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P170016 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 36 – 77 Degrees Fahrenheit